Devices · Biosense Webster, Inc.
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc. is listed for CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207). The FDA list gives September 7, 2023 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DQK. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231207
- Date of final decision
- September 7, 2023
- Company on the FDA list
- Biosense Webster, Inc.
- Lead panel
- Cardiovascular
- Primary product code
- DQK
- openFDA device name for the code
- Computer, Diagnostic, Programmable
- Device class
- 2
- Regulation number
- 870.1425
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary